CA-1 AED Plus Automated External Defibrillator

Nom de l'organisation

Innomed Medical Orvostechnikai Fejlesztő és Gyártó zártkörűen működő részvénytársaság

SRN

HU-MF-000017747

Statut du fabricant

Actif

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Marché principal en Hongrie ; disponible dans 32 pays au total.

Dénomination commerciale

CA-1 AED Plus Automated External Defibrillator

Code d'UDI-DI

D-CA-1AEDPlusHV

Basic UDI-DI

B-CA-1AEDPlusHV

Numéro de référence/catalogue

KCA1P

Entité d'attribution

EUDAMED

Catégorie de risque

Classe IIb

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The CardioAid-1 AED Plus defibrillator is an instrument serving for stopping the ventricular fibrillation; it can change the electric operation of the heart, by applying a high energy impulse. In case of ventricular tachycardia, atrial fibrillation (cardioversion) the defibrillator can restore the normal operation, by applying synchronous defibrillation. In case of sinus tachycardia, bradycardia or strong arrhythmia, the device can normalize the heart operation, in pacing mode. The device has LOW ENERGY BIPHASIC OUTPUT WAVEFORM with patient impedance compensation up to [200-270 J] to shock all VF and VT arrhythmias. Additionally the device supports an extra high [360 J] biphasic energy selection feature for unusual, irregular circumstances in case of overweight patients without causing any additional damage to the heart muscle that is a safe additional energy option for the physician to improve the lifesaving capability of the device. In defibrillation mode the device performs Innomed Biophase® waveform, biphasic output waveform and in pacing mode it performs rectangular current impulse. The CardioAid-1 AED Plus can be used with an optional CPR module – called Innomed CPR module. The CPR module has been developed to give efficient assistance to the doctors, first-aid trainers, resuscitation instructors, untrained NHS employee and bystanders. The unit controls and gives audible voice prompts about the quality of CPR performed by the operator. So the Innomed CPR module is an extremely useful device either is used for student educational purposes (HLE). The defibrillator has the following modes of operation: SEMI-AUTOMATIC MODE, MANUAL ASYNCHRONOUS AND SYNCHRONOUS MODE (FOR SKILLED PERSON ONLY), PACER MODE (FOR SKILLED PERSON ONLY), ADVANCED LIFE SUPPORT (ALS) AND BASIC LIFE SUPPORT (BLS) WITH CPR MODULE.

URL des informations complémentaires

https://www.innomed.hu/en/#contact

Dimensions cliniques

• Min. 2 mV / 0,25 ms; Max. 700 mV / 2 ms
• 20-300 Ohm (1000 Ohm in case of external pace)
• Max. 20 ms
• Sampling frequency — 2000 MU27
• 1 µV/bit
• 200 µV
• 15-300 BPM; ± 2 BPM or 1%
• Li-MnO2 battery 4200mAh /15V
• In case of normal use, at least 24 months (e.g., one charging cycle per day) or 4 years in standby mode
• „Demand” (VVI) or „Normal” (VOO)
• Rectangular, constant current
• 40 ms ± 10%
• Pacemaker Pulse amplitude step — 0.001 MU107
• Variable 1 – 200mA ± 10% or ± 2 mA, default: 0mA
• 1 bpm
• Variable 30 – 200 bpm ± 5%. Default 60 bpm
• Max. 200 V
• 1000
• 275 MU50
• 219 MU50
• 78 MU50
• With battery: 2040 g; w.o. battery: 1715 g
• Manual mode, pacer mode, synchronous mode, Semi-auto mode
• 95.04x53.86 mm 4.3” color TFT display
• 1 ECG lead
• Innomed Biophase® Waveform
• Adult mode: #1=150J, #2=200J, #3=270J, #N =360J; Pediatric mode: #1=50J, #2=50J, #3=80J, #N=100J
• Adult: 2-5-7-10-20-30-40-50-60-80-100-150-200-270-360 [J]; Pediatric: 2-5-7-10-20-30-40-50-60-80-100 [J]
• Automatic disarm after 30s
• ±2J or ±15%, which one is higher, in case of shocks delivered at any energy level for 50ohm loading.
• to 200J: New battery: ≤ 6s, After 15 pulses ≤ 7s; to 360J: new battery: < 10s, after 15 pulses: < 15 s
• Max. 30 µVpp
• ± 10 mV
• ± 400 mV
• 2...50 Hz, -3±1 dB
• 480 x 272 pixel
• Min. 100 dB
• < 2 s

• Z12030501SEMI-AUTOMATIC DEFIBRILLATORS

• Numéro de lot
• Date d'expiration
• Date de fabrication
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• Identification du logiciel